UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016497 |
|---|---|
| Receipt number | R000019157 |
| Scientific Title | The feasibility study: the evaluation of the tissue elasticity of amidominal organs with ultrasound elastography |
| Date of disclosure of the study information | 2015/02/12 |
| Last modified on | 2023/08/17 13:51:54 |
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Basic information
Public title
The feasibility study: the evaluation of the tissue elasticity of amidominal organs with ultrasound elastography
Acronym
N-ELST-study
Scientific Title
The feasibility study: the evaluation of the tissue elasticity of amidominal organs with ultrasound elastography
Scientific Title:Acronym
N-ELST-study
Region
| Japan |
Condition
Condition
abdominal organs
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the tissue elasticity of abominal organs with ultrasound elastography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the tissue elasticity value of each organs, each diseases.
Key secondary outcomes
Incidence of complication
Correlation tissue elasticity with organ function
Change of tissue elasticity by intervention
Diagonositic performance of elastography of each diseases
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients without severe organ function.
2)Patiensts who provided written informed consent
Key exclusion criteria
1)Patients who have severe comlications
2)Patients with severe mental disorder
3)Patients judged as inappropriate by attendant doctor
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Ishikawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
4668550
Address
65 Tsuruma-cho, Showa-ku, Nagoya
TEL
052-744-2602
ishitaku@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Ishikawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
4668550
Address
65 Tsuruma-cho, Showa-ku, Nagoya
TEL
052-744-2602
Homepage URL
ishitaku@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine Department of Gastroenterlogy and Hepatology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Nagoya University Hospital
Address
65 Tsurumai-cho, Showa-ku
Tel
0527442602
center@med.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Under recruiting
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 02 | Month | 12 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2015 | Year | 02 | Month | 09 | Day |
Last modified on
| 2023 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019157
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
